Application 209575

Type: NDA
Sponsor: CODY LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUMBRINO	COCAINE HYDROCHLORIDE	SOLUTION;NASAL	4%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209575-001	NUMBRINO	COCAINE HYDROCHLORIDE	4%	SOLUTION / NASAL		RLD, RS	2020-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209575-001	10016407	2037-02-07	U-2225		2023-08-28
N209575-001	10016407	2037-02-07	U-2226		2023-08-28
N209575-001	10016407	2037-02-07	U-2329		2023-08-28
N209575-001	10149843	2037-02-07	U-2478		2023-08-28
N209575-001	10149843	2037-02-07	U-2479		2023-08-28
N209575-001	10231961	2037-02-07		Drug product	2023-08-28
N209575-001	10413505	2037-02-07	U-3014		2023-08-28
N209575-001	10420760	2037-02-07	U-2478		2023-08-28
N209575-001	10857095	2037-02-07	U-3014		2023-08-28
N209575-001	10894012	2037-02-07	U-3014		2023-08-28
N209575-001	10933060	2037-02-07	U-2478		2023-08-28
N209575-001	10933060	2037-02-07	U-3014		2023-08-28
N209575-001	10973811	2037-02-07	U-3680		2023-08-28
N209575-001	11040032	2037-02-07		Drug product	2023-08-28
N209575-001	9867815	2037-02-07	U-2225		2023-08-28
N209575-001	9867815	2037-02-07	U-2226		2023-08-28
N209575-001	9867815	2037-02-07	U-2227		2023-08-28
N209575-001	9867815	2037-02-07	U-2329		2023-08-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209575-001	NUMBRINO	4%	SOLUTION / NASAL		2020-01-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209575-001	NUMBRINO	4%	SOLUTION / NASAL	RLD, RS	2020-01-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209575-001	10016407	2037-02-07	U-2225		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10016407	2037-02-07	U-2226		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10016407	2037-02-07	U-2329		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10149843	2037-02-07	U-2478		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10149843	2037-02-07	U-2479		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10231961	2037-02-07		Drug product	2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10413505	2037-02-07	U-3014		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10420760	2037-02-07	U-2478		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10857095	2037-02-07	U-3014		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10894012	2037-02-07	U-3014		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10933060	2037-02-07	U-2478		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10933060	2037-02-07	U-3014		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	10973811	2037-02-07	U-3680		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	11040032	2037-02-07		Drug product	2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	9867815	2037-02-07	U-2225		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	9867815	2037-02-07	U-2329		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	9867815	2037-02-07	U-2227		2023-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209575-001	9867815	2037-02-07	U-2226		2023-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10016407	2037-02-07	U-2225		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10016407	2037-02-07	U-2226		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10016407	2037-02-07	U-2329		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10149843	2037-02-07	U-2478		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10149843	2037-02-07	U-2479		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10231961	2037-02-07		Drug product	2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10413505	2037-02-07	U-3014		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10420760	2037-02-07	U-2478		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10857095	2037-02-07	U-3014		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10894012	2037-02-07	U-3014		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10933060	2037-02-07	U-2478		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10933060	2037-02-07	U-3014		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	10973811	2037-02-07	U-3680		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	11040032	2037-02-07		Drug product	2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	9867815	2037-02-07	U-2225		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	9867815	2037-02-07	U-2329		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	9867815	2037-02-07	U-2227		2023-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209575-001	9867815	2037-02-07	U-2226		2023-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209575-001	10016407	2037-02-07	U-2225		2023-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209575-001	10016407	2037-02-07	U-2226		2023-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209575-001	10016407	2037-02-07	U-2329		2023-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209575-001	10149843	2037-02-07	U-2478		2023-08-28	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209575-001	NCE	2022-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209575-001	NP	2023-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209575-001	NCE	2022-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209575-001	NP	2023-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209575-001	NCE	2022-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209575-001	NP	2023-01-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209575-001	NCE	2022-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209575-001	NP	2023-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209575-001	NCE	2022-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209575-001	NP	2023-01-10	`782e0a99824c…`
2023-12-20 04:57 UTC	2023-12	N209575-001	NP	2023-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209575-001	NP	2023-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209575-001	NP	2023-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209575-001	NP	2023-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209575-001	NP	2023-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209575-001	NP	2023-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209575-001	NCE	2022-12-14	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209575-001	NP	2023-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209575-001	NCE	2022-12-14	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209575-001	NP	2023-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209575-001	NCE	2022-12-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209575-001	NP	2023-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209575-001	NCE	2022-12-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N209575-001	NP	2023-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209575-001	NCE	2022-12-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209575-001	NP	2023-01-10	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUMBRINO	COCAINE HYDROCHLORIDE NASAL	OMNIVIUM PHARMACEUTICALS LLC.	d724b5b4-6654-4bf5-9eed-e2c7943084ed	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209575 application number: NDA209575
cocaine hydrochloride nasal	COCAINE HYDROCHLORIDE NASAL	OMNIVIUM PHARMACEUTICALS LLC.	4e3b2f6b-1b57-40bc-872b-01c0a3c7986e	2023-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209575 application number: NDA209575

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1961	NUMBRINO	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA	Current
0527-1971	cocaine hydrochloride nasal	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-1971	cocaine hydrochloride nasal	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-1971	cocaine hydrochloride nasal	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current
0527-1971	cocaine hydrochloride nasal	cocaine hydrochloride nasal	Lannett Company, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64440	SUPPL	2020-08-28
63372	ORIG	2020-06-01
61573	ORIG	2020-01-14
61564	ORIG	2020-01-14